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Trial record 1 of 1 for:    NCT00938431
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A Multicenter, Open-Label Study To Investigate The Safety And Pharmacokinetics Of Lacosamide In Children With Partial Seizures

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00938431
Recruitment Status : Completed
First Posted : July 13, 2009
Results First Posted : December 15, 2015
Last Update Posted : March 19, 2019
Sponsor:
Information provided by (Responsible Party):
UCB Pharma

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Epilepsy
Intervention Drug: Lacosamide
Enrollment 47
Recruitment Details The SP0847 study began recruitment in October 2009. The study ended in July 2014 with 47 subjects enrolled into the study.
Pre-assignment Details  
Arm/Group Title >=1 Month to <4 Years (Safety Set) >=4 Years to <12 Years (Safety Set) >=12 Years to <=17 Years (Safety Set)
Hide Arm/Group Description Subjects were classified as belonging to the age group based on their age at time of enrollment Subjects were classified as belonging to the age group based on their age at time of enrollment Subjects were classified as belonging to the age group based on their age at time of enrollment
Period Title: Overall Study
Started 15 23 9
Completed 9 14 1
Not Completed 6 9 8
Reason Not Completed
Adverse Event             5             8             6
Lack of Efficacy             0             1             0
Did not up titrate to 12 mg kg/day             1             0             0
Dosing compliance issue             0             0             1
Reached maximum dose early             0             0             1
Arm/Group Title >=1 Month to <4 Years (Safety Set) >=4 Years to <12 Years (Safety Set) >=12 Years to <=17 Years (Safety Set) Total Title
Hide Arm/Group Description Subjects were classified as belonging to the age group based on their age at time of enrollment Subjects were classified as belonging to the age group based on their age at time of enrollment Subjects were classified as belonging to the age group based on their age at time of enrollment [Not Specified]
Overall Number of Baseline Participants 15 23 9 47
Hide Baseline Analysis Population Description
The analysis group for Baseline Characteristics is the Safety Set (SS). The SS is all subjects who signed the informed consent form and took at least 1 dose of Lacosamide (LCM) in SP0847.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Age (years) Number Analyzed 15 participants 23 participants 9 participants 47 participants
1.58  (1.02) 7.41  (2.44) 15.15  (1.50) 7.03  (5.12)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 15 participants 23 participants 9 participants 47 participants
Female
10
  66.7%
9
  39.1%
5
  55.6%
24
  51.1%
Male
5
  33.3%
14
  60.9%
4
  44.4%
23
  48.9%
Weight  
Mean (Standard Deviation)
Unit of measure:  Kilograms
Number Analyzed 15 participants 23 participants 9 participants 47 participants
9.90  (3.31) 26.73  (10.20) 54.10  (10.49) 26.60  (17.64)
Height  
Mean (Standard Deviation)
Unit of measure:  Centimeters
Number Analyzed 15 participants 23 participants 9 participants 47 participants
79.64  (11.22) 121.81  (14.86) 158.93  (11.43) 115.46  (31.23)
BMI  
Mean (Standard Deviation)
Unit of measure:  Kg/m^2
Number Analyzed 15 participants 23 participants 9 participants 47 participants
15.27  (2.33) 17.39  (2.68) 21.38  (3.12) 17.48  (3.37)
Racial Group  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 15 participants 23 participants 9 participants 47 participants
Asian 1 1 0 2
Black 0 4 3 7
White 7 18 5 30
Other/ Mixed 7 0 1 8
Ethnicity  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 15 participants 23 participants 9 participants 47 participants
Hispanic or Latino 11 7 3 21
Not Hispanic or Latino 4 16 6 26
1.Primary Outcome
Title Number of Subjects That Report at Least One Treatment-emergent Adverse Event During the Study (Approximately 13 Weeks)
Hide Description [Not Specified]
Time Frame 13 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis consists of the Safety Set (SS), which is all subjects who signed the informed consent form and took at least 1 dose of Lacosamide (LCM) in SP0847.
Arm/Group Title >=1 Month to <4 Years (Safety Set) >=4 Years to <12 Years (Safety Set) >=12 Years to <=17 Years (Safety Set)
Hide Arm/Group Description:
Subjects were classified as belonging to the age group based on their age at time of enrollment
Subjects were classified as belonging to the age group based on their age at time of enrollment
Subjects were classified as belonging to the age group based on their age at time of enrollment
Overall Number of Participants Analyzed 15 23 9
Measure Type: Number
Unit of Measure: participants
14 19 9
2.Secondary Outcome
Title Change in Seizure Frequency From Baseline to End of Treatment
Hide Description [Not Specified]
Time Frame From Baseline to End of Treatment (approximately 13 weeks)
Hide Outcome Measure Data
Hide Analysis Population Description
This analysis consists of the Full Analysis Set, which is all subjects from the Safety Set who have at least 1 post-Baseline seizure diary day with available data during the SP0847 study.
Arm/Group Title >=1 Month to <4 Years (Full Analysis Set) >=4 Years to <12 Years (Full Analysis Set) >=12 Years to <=17 Years (Full Analysis Set)
Hide Arm/Group Description:
Subjects were classified as belonging to the age group based on their age at time of enrollment
Subjects were classified as belonging to the age group based on their age at time of enrollment
Subjects were classified as belonging to the age group based on their age at time of enrollment
Overall Number of Participants Analyzed 14 23 9
Mean (Standard Deviation)
Unit of Measure: percentage change
18.94  (111.44) 18.38  (88.16) 34.59  (92.45)
3.Secondary Outcome
Title Caregiver Global Impression of Change Score at Visit 5 (Day 27/28) or Early Termination
Hide Description

For the assessment of the Caregiver Global Impression of Change, the caregiver (including parent/legal guardian) provided his/her assessment of the subject's clinical status, compared to Baseline (Visit 1), including an evaluation of seizure frequency and intensity, the occurrence of Adverse Events (AEs), and subject's functional status.

The caregiver will be asked to check the number that best describes the subject's condition over the past 4 weeks compared to Baseline:

  1. Very much improved
  2. Much improved
  3. Minimally improved
  4. No change
  5. Minimally worse
  6. Much worse
  7. Very much worse
Time Frame Visit 5 (Day 27/28) or Early Termination
Hide Outcome Measure Data
Hide Analysis Population Description
This analysis consists of the Full Analysis Set, which is all subjects from the Safety Set who have at least 1 post-Baseline seizure diary day with available data during the SP0847 study.
Arm/Group Title >=1 Month to <4 Years (Full Analysis Set) >=4 Years to <12 Years (Full Analysis Set) >=12 Years to <=17 Years (Full Analysis Set)
Hide Arm/Group Description:
Subjects were classified as belonging to the age group based on their age at time of enrollment
Subjects were classified as belonging to the age group based on their age at time of enrollment
Subjects were classified as belonging to the age group based on their age at time of enrollment
Overall Number of Participants Analyzed 14 23 9
Measure Type: Number
Unit of Measure: Participants
Very Much Improved 3 2 0
Much Improved 7 8 4
Minimally Improved 3 8 3
No Change 0 2 1
Miniamally Worse 0 1 0
Much Worse 0 2 0
No data available 1 0 1
4.Secondary Outcome
Title Clinical Global Impression of Change Score at Visit 5 (Day 27/28) or Early Termination
Hide Description

For assessment of the Clinical Global Impression of Change, the investigator provided his/her assessment of the subject's clinical status, compared to Baseline (Visit 1), including an evaluation of seizure frequency and intensity, the occurrence of AEs, and subject's functional status.

The investigator will be asked to check the number that best describes the subject's condition over the past 4 weeks compared to Baseline:

  1. Very much improved
  2. Much improved
  3. Minimally improved
  4. No Change
  5. Minimally worse
  6. Much worse
  7. Very much worse
Time Frame Visit 5 (Day 27/28) or Early Termination
Hide Outcome Measure Data
Hide Analysis Population Description

This analysis consists of the Full Analysis Set, which is all subjects from the Safety Set who have at least 1 post-Baseline seizure diary day with available data during the SP0847 study.

For one subject in the age group >=12 years to <=17 years no data is available.

Arm/Group Title >=1 Month to <4 Years (Full Analysis Set) >=4 Years to <12 Years (Full Analysis Set) >=12 Years to <=17 Years (Full Analysis Set)
Hide Arm/Group Description:
Subjects were classified as belonging to the age group based on their age at time of enrollment
Subjects were classified as belonging to the age group based on their age at time of enrollment
Subjects were classified as belonging to the age group based on their age at time of enrollment
Overall Number of Participants Analyzed 14 23 9
Measure Type: Number
Unit of Measure: Participants
Very Much Improved 2 2 0
Much Improved 6 7 7
Minimally Improved 4 9 1
No Change 1 2 0
Minimally Worse 0 3 0
Much Worse 1 0 0
No data available 0 0 1
5.Secondary Outcome
Title Plasma Ctrough Values for Lacosamide at Day 7
Hide Description

During SP0847, the time points for collection of blood samples for plasma concentration analysis varied per enrollment cohort. To provide a standard summary of this information, we present the mean plasma trough concentrations (Ctrough). Ctrough levels represent the lowest level of LCM that was present in the subject with measurement taken pre-dose before the next scheduled dose of LCM.

The blood sample for plasma concentration schedule varied per enrollment cohort and with protocol amendments. A PK sample was not required for a subject to be in the included in the SS although all subjects did have at least one PK sample taken during SP0847. Therefore the number of subjects presented for the PK assessments is based on the subjects in the SS who attended the respective visits and had PK concentration data at the respective time point.

Time Frame Day 7
Hide Outcome Measure Data
Hide Analysis Population Description

The analysis consists of the Safety Set, which is all subjects who signed the informed consent form and took at least 1 dose of LCM in SP0847.

The number of subjects presented for the PK assessments is based on the subjects in the SS who attended the respective visits and had PK concentration data at the respective time point.

Arm/Group Title All Subjects (Safety Set)
Hide Arm/Group Description:
All subjects from >=1 month to <=17 years
Overall Number of Participants Analyzed 45
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: μg/mL
839.9
(64.1%)
6.Secondary Outcome
Title Plasma Ctrough Values for Lacosamide at Day 28
Hide Description

During SP0847, the time points for collection of blood samples for plasma concentration analysis varied per enrollment cohort. To provide a standard summary of this information, we present the mean plasma trough concentrations (Ctrough). Ctrough levels represent the lowest level of LCM that was present in the subject with measurement taken pre-dose before the next scheduled dose of LCM.

The blood sample for plasma concentration schedule varied per enrollment cohort and with protocol amendments. A PK sample was not required for a subject to be in the included in the SS although all subjects did have at least one PK sample taken during SP0847. Therefore the number of subjects presented for the PK assessments is based on the subjects in the SS who attended the respective visits and had PK concentration data at the respective time point.

Time Frame Day 28
Hide Outcome Measure Data
Hide Analysis Population Description

The analysis consists of the Safety Set, which is all subjects who signed the informed consent form and took at least 1 dose of LCM in SP0847.

The number of subjects presented for the PK assessments is based on the subjects in the SS who attended the respective visits and had PK concentration data at the respective time point.

Arm/Group Title All Subjects (Safety Set)
Hide Arm/Group Description:
All subjects from >=1 month to <=17 years
Overall Number of Participants Analyzed 6
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: μg/mL
3886.0
(70.2%)
7.Secondary Outcome
Title Plasma Ctrough Values for Lacosamide at Day 35
Hide Description

During SP0847, the time points for collection of blood samples for plasma concentration analysis varied per enrollment cohort. To provide a standard summary of this information, we present the mean plasma trough concentrations (Ctrough). Ctrough levels represent the lowest level of LCM that was present in the subject with measurement taken pre-dose before the next scheduled dose of LCM.

The blood sample for plasma concentration schedule varied per enrollment cohort and with protocol amendments. A PK sample was not required for a subject to be in the included in the SS although all subjects did have at least one PK sample taken during SP0847. Therefore the number of subjects presented for the PK assessments is based on the subjects in the SS who attended the respective visits and had PK concentration data at the respective time point.

Time Frame Day 35
Hide Outcome Measure Data
Hide Analysis Population Description

The analysis consists of the Safety Set, which is all subjects who signed the informed consent form and took at least 1 dose of LCM in SP0847.

The number of subjects presented for the PK assessments is based on the subjects in the SS who attended the respective visits and had PK concentration data at the respective time point.

Arm/Group Title All Subjects (Safety Set)
Hide Arm/Group Description:
All subjects from >=1 month to <=17 years
Overall Number of Participants Analyzed 5
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: μg/mL
4033.8
(52.5%)
8.Secondary Outcome
Title Plasma Ctrough Values for Lacosamide at Day 42
Hide Description

During SP0847, the time points for collection of blood samples for plasma concentration analysis varied per enrollment cohort. To provide a standard summary of this information, we present the mean plasma trough concentrations (Ctrough). Ctrough levels represent the lowest level of LCM that was present in the subject with measurement taken pre-dose before the next scheduled dose of LCM.

The blood sample for plasma concentration schedule varied per enrollment cohort and with protocol amendments. A PK sample was not required for a subject to be in the included in the SS although all subjects did have at least one PK sample taken during SP0847. Therefore the number of subjects presented for the PK assessments is based on the subjects in the SS who attended the respective visits and had PK concentration data at the respective time point.

Time Frame Day 42
Hide Outcome Measure Data
Hide Analysis Population Description

The analysis consists of the Safety Set, which is all subjects who signed the informed consent form and took at least 1 dose of LCM in SP0847.

The number of subjects presented for the PK assessments is based on the subjects in the SS who attended the respective visits and had PK concentration data at the respective time point.

Arm/Group Title All Subjects (Safety Set)
Hide Arm/Group Description:
All subjects from >=1 month to <=17 years
Overall Number of Participants Analyzed 14
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: μg/mL
4169.5
(73.3%)
9.Secondary Outcome
Title Plasma Ctrough Values for SPM 12809 at Day 7
Hide Description

SPM 12809 is major metabolite of LCM and is known as O-desmethyl-lacosamide. During SP0847, the time points for collection of blood samples for plasma concentration analysis varied per enrollment cohort. To provide a standard summary of this information, we present the mean plasma trough concentrations (Ctrough). Ctrough levels represent the lowest level of LCM that was present in the subject with measurement taken pre-dose before the next scheduled dose of LCM.

The blood sample for plasma concentration schedule varied per enrollment cohort and with protocol amendments. A PK sample was not required for a subject to be in the included in the SS although all subjects did have at least one PK sample taken during SP0847. Therefore the number of subjects presented for the PK assessments is based on the subjects in the SS who attended the respective visits and had PK concentration data at the respective time point.

Time Frame Day 7
Hide Outcome Measure Data
Hide Analysis Population Description

The analysis consists of the Safety Set, which is all subjects who signed the informed consent form and took at least 1 dose of LCM in SP0847.

The number of subjects presented for the PK assessments is based on the subjects in the SS who attended the respective visits and had PK concentration data at the respective time point.

Arm/Group Title All Subjects (Safety Set)
Hide Arm/Group Description:
All subjects from >=1 month to <=17 years
Overall Number of Participants Analyzed 45
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: μg/mL
258.4
(44.6%)
10.Secondary Outcome
Title Plasma Ctrough Values for SPM 12809 at Day 28
Hide Description

SPM 12809 is major metabolite of LCM and is known as O-desmethyl-lacosamide. During SP0847, the time points for collection of blood samples for plasma concentration analysis varied per enrollment cohort. To provide a standard summary of this information, we present the mean plasma trough concentrations (Ctrough). Ctrough levels represent the lowest level of LCM that was present in the subject with measurement taken pre-dose before the next scheduled dose of LCM.

The blood sample for plasma concentration schedule varied per enrollment cohort and with protocol amendments. A PK sample was not required for a subject to be in the included in the SS although all subjects did have at least one PK sample taken during SP0847. Therefore the number of subjects presented for the PK assessments is based on the subjects in the SS who attended the respective visits and had PK concentration data at the respective time point.

Time Frame Day 28
Hide Outcome Measure Data
Hide Analysis Population Description

The analysis consists of the Safety Set, which is all subjects who signed the informed consent form and took at least 1 dose of LCM in SP0847.

The number of subjects presented for the PK assessments is based on the subjects in the SS who attended the respective visits and had PK concentration data at the respective time point.

Arm/Group Title All Subjects (Safety Set)
Hide Arm/Group Description:
All subjects from >=1 month to <=17 years
Overall Number of Participants Analyzed 6
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: μg/mL
754.9
(21.1%)
11.Secondary Outcome
Title Plasma Ctrough Values for SPM 12809 at Day 35
Hide Description

SPM 12809 is major metabolite of LCM and is known as O-desmethyl-lacosamide. During SP0847, the time points for collection of blood samples for plasma concentration analysis varied per enrollment cohort. To provide a standard summary of this information, we present the mean plasma trough concentrations (Ctrough). Ctrough levels represent the lowest level of LCM that was present in the subject with measurement taken pre-dose before the next scheduled dose of LCM.

The blood sample for plasma concentration schedule varied per enrollment cohort and with protocol amendments. A PK sample was not required for a subject to be in the included in the SS although all subjects did have at least one PK sample taken during SP0847. Therefore the number of subjects presented for the PK assessments is based on the subjects in the SS who attended the respective visits and had PK concentration data at the respective time point.

Time Frame Day 35
Hide Outcome Measure Data
Hide Analysis Population Description

The analysis consists of the Safety Set, which is all subjects who signed the informed consent form and took at least 1 dose of LCM in SP0847.

The number of subjects presented for the PK assessments is based on the subjects in the SS who attended the respective visits and had PK concentration data at the respective time point.

Arm/Group Title All Subjects (Safety Set)
Hide Arm/Group Description:
All subjects from >=1 month to <=17 years
Overall Number of Participants Analyzed 5
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: μg/mL
955.1
(24.7%)
12.Secondary Outcome
Title Plasma Ctrough Values for SPM 12809 at Day 42
Hide Description

SPM 12809 is major metabolite of LCM and is known as O-desmethyl-lacosamide. During SP0847, the time points for collection of blood samples for plasma concentration analysis varied per enrollment cohort. To provide a standard summary of this information, we present the mean plasma trough concentrations (Ctrough). Ctrough levels represent the lowest level of LCM that was present in the subject with measurement taken pre-dose before the next scheduled dose of LCM.

The blood sample for plasma concentration schedule varied per enrollment cohort and with protocol amendments. A PK sample was not required for a subject to be in the included in the SS although all subjects did have at least one PK sample taken during SP0847. Therefore the number of subjects presented for the PK assessments is based on the subjects in the SS who attended the respective visits and had PK concentration data at the respective time point.

Time Frame Day 42
Hide Outcome Measure Data
Hide Analysis Population Description

The analysis consists of the Safety Set, which is all subjects who signed the informed consent form and took at least 1 dose of LCM in SP0847.

The number of subjects presented for the PK assessments is based on the subjects in the SS who attended the respective visits and had PK concentration data at the respective time point.

Arm/Group Title All Subjects (Safety Set)
Hide Arm/Group Description:
All subjects from >=1 month to <=17 years
Overall Number of Participants Analyzed 14
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: μg/mL
1725.8
(39.4%)
Time Frame Adverse Events (AE) and Serious Adverse Events (SAE) were recorded for the duration of the study (November 2009 - July 2014). The analysis group for AEs and SAEs was the Safety Set.
Adverse Event Reporting Description The Safety Set comprised of all subjects who signed the informed consent form and took at least 1 dose of Lacosamide in SP0847.
 
Arm/Group Title >=1 Month to <4 Years (Safety Set) >=4 Years to <12 Years (Safety Set) >=12 Years to <=17 Years (Safety Set)
Hide Arm/Group Description Subjects were classified as belonging to the age group based on their age at time of enrollment Subjects were classified as belonging to the age group based on their age at time of enrollment Subjects were classified as belonging to the age group based on their age at time of enrollment
All-Cause Mortality
>=1 Month to <4 Years (Safety Set) >=4 Years to <12 Years (Safety Set) >=12 Years to <=17 Years (Safety Set)
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--      --/--    
Hide Serious Adverse Events
>=1 Month to <4 Years (Safety Set) >=4 Years to <12 Years (Safety Set) >=12 Years to <=17 Years (Safety Set)
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   3/15 (20.00%)      3/23 (13.04%)      0/9 (0.00%)    
Gastrointestinal disorders       
Gastrointestinal inflammation * 1  0/15 (0.00%)  0 1/23 (4.35%)  1 0/9 (0.00%)  0
Infections and infestations       
Pneumonia viral * 1  1/15 (6.67%)  1 0/23 (0.00%)  0 0/9 (0.00%)  0
Viral upper respiratory tract infection * 1  0/15 (0.00%)  0 1/23 (4.35%)  1 0/9 (0.00%)  0
Metabolism and nutrition disorders       
Dehydration * 1  1/15 (6.67%)  1 0/23 (0.00%)  0 0/9 (0.00%)  0
Nervous system disorders       
Status epilepticus * 1  2/15 (13.33%)  2 1/23 (4.35%)  1 0/9 (0.00%)  0
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA16.1
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
>=1 Month to <4 Years (Safety Set) >=4 Years to <12 Years (Safety Set) >=12 Years to <=17 Years (Safety Set)
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   11/15 (73.33%)      16/23 (69.57%)      7/9 (77.78%)    
Gastrointestinal disorders       
Vomiting * 1  1/15 (6.67%)  3 7/23 (30.43%)  7 2/9 (22.22%)  2
Diarrhoea * 1  2/15 (13.33%)  2 4/23 (17.39%)  7 1/9 (11.11%)  1
Constipation * 1  1/15 (6.67%)  1 1/23 (4.35%)  1 1/9 (11.11%)  1
General disorders       
Irritability * 1  3/15 (20.00%)  3 1/23 (4.35%)  1 1/9 (11.11%)  1
Pyrexia * 1  2/15 (13.33%)  2 3/23 (13.04%)  4 0/9 (0.00%)  0
Gait disturbance * 1  0/15 (0.00%)  0 2/23 (8.70%)  2 1/9 (11.11%)  1
Infections and infestations       
Otitis media * 1  0/15 (0.00%)  0 3/23 (13.04%)  3 0/9 (0.00%)  0
Pharyngotonsillitis * 1  3/15 (20.00%)  3 0/23 (0.00%)  0 0/9 (0.00%)  0
Nervous system disorders       
Somnolence * 1  2/15 (13.33%)  2 3/23 (13.04%)  3 1/9 (11.11%)  1
Dizziness * 1  0/15 (0.00%)  0 3/23 (13.04%)  4 2/9 (22.22%)  2
Balance disorder * 1  0/15 (0.00%)  0 1/23 (4.35%)  2 2/9 (22.22%)  2
Skin and subcutaneous tissue disorders       
Rash * 1  1/15 (6.67%)  1 1/23 (4.35%)  1 2/9 (22.22%)  2
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA16.1
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
UCB has > 60 but <= 180 days to review results communications prior to public release and may delete information that is confidential and compromises ongoing studies or is considered proprietary. This restriction is not intended to compromise the objective scientific integrity of the manuscript, it being understood that the results shall be published regardless of outcome.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Study Director
Organization: UCB
Phone: +1877 822 9493
Layout table for additonal information
Responsible Party: UCB Pharma
ClinicalTrials.gov Identifier: NCT00938431    
Other Study ID Numbers: SP0847
2011-001558-27 ( EudraCT Number )
First Submitted: July 2, 2009
First Posted: July 13, 2009
Results First Submitted: June 29, 2015
Results First Posted: December 15, 2015
Last Update Posted: March 19, 2019